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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Dialysate Ph Indicator
510(k) Number K941599
Device Name MITEK ABSORBABLE ANCHOR
Applicant
Mitek Surgical Products, Inc.
60 Glacier Dr.
Westwood,  MA  02090
Applicant Contact EDWARD F KENT
Correspondent
Mitek Surgical Products, Inc.
60 Glacier Dr.
Westwood,  MA  02090
Correspondent Contact EDWARD F KENT
Regulation Number876.5820
Classification Product Code
MNV  
Date Received04/01/1994
Decision Date 10/24/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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